Bone Augmentation Clinical Trial
Official title:
Phase I/II Open Label First in Human Single Center Clinical Study Aimed to Evaluate the Safety and Efficacy of BonoFill-II in Reconstructing Maxillofacial Bone
The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II as a bone filler containing the patient's own (autologous) adipose (fat) tissue-derived cells in reconstructing bone in two clinical indications: 1. Bone augmentation (e.g. sinus augmentation) 2. Bone grafting after removal of cysts from jaws
Primary endpoint: The transplantation of BonoFill-II to the maxillary or mandible defect/void is safe under the following conditions: No chronic bone infection (Osteomyelitis); no significant changes in complete blood count (CBC) and in general health. Secondary endpoint: The transplantation of BonoFill-II to the maxillary or mandible void is efficient under the following conditions: Following BonoFill-II implantation, the bone regeneration in the operated site was significantly accelerated. Also, the bone defects/voids were filled with a significant amount of bone tissue. ;
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